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Interviews

In this exclusive interview Dawn Fowler, Senior Manager, Labeling & Documentation Endologix, speaks to Andrea Charles from Pharma IQ about the benefits of UDI implementation beyond compliance and why it is important to ensure ROI from your UDI project. Fowler shares key lessons learnt from trying to realise return on investment from a UDI project and how to manage and utilise the new volumes of data created by UDI implementation.

In this Pharma IQ interview, Regina Au from BioMarketing Insight shares her insights on the current UDIs for medical devices landscape and the impact of the FDA’s final rule on UDIs on the medical device industry, both in the US and on a global scale. Au also reveals the 5 key business benefits for medical device manufacturers.

Following the demand for increased accountability and traceability with medical devices to safeguard patient safety, manufacturers must meet the expectation to bring printing, labelling technologies and master data management up to compliance standards. This will involve developing a UDI corporate strategy and policy for all business units and departments.

On the road to meeting compliance deadlines and executing a UDI project one key step will be pinpointing any gaps between existing supply chain systems to UDI requirements. This will involve analysing the supply chain process, transit issues, the mechanics of recalls and reporting on a UDI compliant product and whether the expected benefits are achieved. Then redesigning and integrating management of product labelling and packaging to enable regulatory compliance. With this large task in mind, we spoke to a couple of experts on the subject of filling the gaps within a UDI strategy.

While the US advances with its coverage of medical device classes within the U.S. Food and Drug Administration (FDA) Unique Device Identification regime, other countries around the globe are progressing their own track and trace strategies for medical devices. Through the collaboration of the world’s regulatory agencies it is hoped that a synchronized approach to medical device identification will be achieved on an international level, amidst their efforts to tackle counterfeiting, increase accountability and enable safety corrective measures. (2)

In early 2013, the European Commission released a recommendation upon a proposed structure for the UDI requirements system in the EU.
Now, the current trilogue negotiation between the three EU institutions – the European Parliament, Council and Commission, is expected to produce the adopted final regulatory text within 2016. Market analysts have forecasted that after this text is agreed and adopted, the industry is likely to be given three years until the regulation will come into force. (5)

As the industry awaits the finalized regulations from the EU, some have looked at the FDA and predicted that the EU is likely to mirror the preferences of the US body.

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The task of realising advantages from deploying UDIs for medical devices stands as a vast project, with the practical challenges of efficient and compliant implementation looming large.

Some of the implementation roadblocks that confront and hinder today’s hospitals include:

Bar codes not being well printed

Unreliable bar codes

Superfluous labels on a device, mostly intended for the manufacturer’s use that drown out the label of interest for the hospital.

With a view to contribute to the industry’s ongoing progression, Pharma IQ collates the lessons learnt by hospitals during the implementation of UDIs for medical devices and how the conduct of manufacturers and hospitals could be altered to not just optimize this project’s roll out but to avoid incurring any detriment.

A selection of experts have highlighted one key hurdle the market should brace for: data management with the EU UDI regime. Due to this area being expected to
differ from the FDA’s GUDID process quite sharply in some places. With the MDR due to come into effect in a few years time, Pharma IQ gains insight on the forecasted data complexities attached to the EU’s UDI gameplan.